{
"info": {
"nct_id": "NCT01503372",
"official_title": "Pazopanib With 5-Fluorouracil, Leucovorin and Oxaliplatin (FLO) as 1st-line Treatment in Advanced Gastric Cancer; a Randomized Phase-II-study of the Arbeitsgemeinschaft Internistische Onkologie",
"inclusion_criteria": "* Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.\n* Age ≥ 18 years.\n* Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction with either metastatic or locally advanced disease, incurable by operation.\n* Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2\n* At least one unidimensional, measurable tumor parameter (according to RECIST 1.1)\n* No preceding cytotoxic therapy (neoadjuvant or adjuvant treatment allowed if finished > 6 months before inclusion)\n* Adequate organ system function.\n* Men and women must perform an adequate contraception.\n* Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Prior malignancy, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.\n* Overexpression of HER-2, defined as IHC 3+ or IHC 2+ and FISH positive.\n* Known hypersensitivity against 5-FU, leukovorin, oxaliplatin or other platinum compounds or pazopanib.\n* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.\n* Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or the absorption of investigational product\n* Presence of uncontrolled infection.\n* Corrected QT interval (QTc) > 480 ms using Bazett's formula.\n* History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, NYHA III or IV congestive heart failure.\n* Poorly controlled hypertension.\n* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.\n* Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.\n* Evidence of active bleeding or bleeding diathesis.\n* Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.\n* Hemoptysis in excess of 2.5 ml within 8 weeks of first dose of study drug.\n* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.\n* Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.\n* Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib. A neoadjuvant or adjuvant chemotherapy must be finished at least 6 month before study entry.\n* Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.\n* Grade 3 or 4 diarrhea.\n* Peripheral polyneuropathy > NCI Grade.\n* Pregnant or lactating women.\n* Men or women who are planning a pregnancy within the next six months.\n* Participation in another clinical trial with investigational agents within the last 30 days prior to study start.\n* The patient is a colleague or employed by the study investigator or by an involved institution including the sponsor of the study.\n* Patient is detained in a psychiatric unit or imprisoned.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.",
"criterions": [
{
"exact_snippets": "Subjects must provide written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "provision",
"expected_value": true
}
]
},
{
"exact_snippets": "must be willing to comply with treatment and follow up",
"criterion": "willingness to comply",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
}
]
},
{
"line": "* Age ≥ 18 years.",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction with either metastatic or locally advanced disease, incurable by operation.",
"criterions": [
{
"exact_snippets": "Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction",
"criterion": "adenocarcinoma",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically"
},
{
"requirement_type": "location",
"expected_value": [
"stomach",
"gastroesophageal junction"
]
}
]
},
{
"exact_snippets": "metastatic or locally advanced disease",
"criterion": "disease stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"metastatic",
"locally advanced"
]
}
]
},
{
"exact_snippets": "incurable by operation",
"criterion": "curability by operation",
"requirements": [
{
"requirement_type": "curability",
"expected_value": false
}
]
}
]
},
{
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* At least one unidimensional, measurable tumor parameter (according to RECIST 1.1)",
"criterions": [
{
"exact_snippets": "At least one unidimensional, measurable tumor parameter (according to RECIST 1.1)",
"criterion": "tumor parameter",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "unidimensional"
}
},
{
"requirement_type": "measurability",
"expected_value": "measurable according to RECIST 1.1"
}
]
}
]
},
{
"line": "* No preceding cytotoxic therapy (neoadjuvant or adjuvant treatment allowed if finished > 6 months before inclusion)",
"criterions": [
{
"exact_snippets": "No preceding cytotoxic therapy",
"criterion": "preceding cytotoxic therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "neoadjuvant or adjuvant treatment allowed if finished > 6 months before inclusion",
"criterion": "neoadjuvant or adjuvant treatment",
"requirements": [
{
"requirement_type": "completion time",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Adequate organ system function.",
"criterions": [
{
"exact_snippets": "Adequate organ system function.",
"criterion": "organ system function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* Men and women must perform an adequate contraception.",
"criterions": [
{
"exact_snippets": "Men and women must perform an adequate contraception.",
"criterion": "contraception",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.",
"criterions": [
{
"exact_snippets": "Female subjects who are lactating",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "status",
"expected_value": "discontinue nursing prior to the first dose of study drug"
},
{
"requirement_type": "status",
"expected_value": "refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Prior malignancy, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.",
"criterions": [
{
"exact_snippets": "Prior malignancy",
"criterion": "prior malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "curatively treated basal cell carcinoma of the skin",
"criterion": "basal cell carcinoma of the skin",
"requirements": [
{
"requirement_type": "treatment status",
"expected_value": "curatively treated"
}
]
},
{
"exact_snippets": "in situ carcinoma of the cervix",
"criterion": "in situ carcinoma of the cervix",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Overexpression of HER-2, defined as IHC 3+ or IHC 2+ and FISH positive.",
"criterions": [
{
"exact_snippets": "Overexpression of HER-2, defined as IHC 3+ or IHC 2+ and FISH positive.",
"criterion": "HER-2 overexpression",
"requirements": [
{
"requirement_type": "IHC score",
"expected_value": [
"3+",
"2+"
]
},
{
"requirement_type": "FISH status",
"expected_value": "positive"
}
]
}
]
},
{
"line": "* Known hypersensitivity against 5-FU, leukovorin, oxaliplatin or other platinum compounds or pazopanib.",
"criterions": [
{
"exact_snippets": "hypersensitivity against 5-FU",
"criterion": "hypersensitivity to 5-FU",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hypersensitivity against ... leukovorin",
"criterion": "hypersensitivity to leukovorin",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hypersensitivity against ... oxaliplatin",
"criterion": "hypersensitivity to oxaliplatin",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hypersensitivity against ... other platinum compounds",
"criterion": "hypersensitivity to other platinum compounds",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hypersensitivity against ... pazopanib",
"criterion": "hypersensitivity to pazopanib",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.",
"criterions": [
{
"exact_snippets": "History or clinical evidence of central nervous system (CNS) metastases",
"criterion": "central nervous system (CNS) metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "History or clinical evidence of ... leptomeningeal carcinomatosis",
"criterion": "leptomeningeal carcinomatosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or the absorption of investigational product",
"criterions": [
{
"exact_snippets": "Clinically significant gastrointestinal abnormalities",
"criterion": "gastrointestinal abnormalities",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "clinically significant"
}
]
},
{
"exact_snippets": "gastrointestinal bleeding",
"criterion": "risk for gastrointestinal bleeding",
"requirements": [
{
"requirement_type": "risk",
"expected_value": true
}
]
},
{
"exact_snippets": "absorption of investigational product",
"criterion": "absorption of investigational product",
"requirements": [
{
"requirement_type": "risk",
"expected_value": true
}
]
}
]
},
{
"line": "* Presence of uncontrolled infection.",
"criterions": [
{
"exact_snippets": "Presence of uncontrolled infection",
"criterion": "infection",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
}
]
},
{
"line": "* Corrected QT interval (QTc) > 480 ms using Bazett's formula.",
"criterions": [
{
"exact_snippets": "Corrected QT interval (QTc) > 480 ms",
"criterion": "corrected QT interval (QTc)",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 480,
"unit": "ms"
}
}
]
}
]
},
{
"line": "* History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, NYHA III or IV congestive heart failure.",
"criterions": [
{
"exact_snippets": "History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting",
"criterion": "cardiac angioplasty or stenting",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": "within the past 6 months"
}
]
},
{
"exact_snippets": "History of any one or more of the following cardiovascular conditions within the past 6 months: ... myocardial infarction",
"criterion": "myocardial infarction",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": "within the past 6 months"
}
]
},
{
"exact_snippets": "History of any one or more of the following cardiovascular conditions within the past 6 months: ... unstable angina",
"criterion": "unstable angina",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": "within the past 6 months"
}
]
},
{
"exact_snippets": "History of any one or more of the following cardiovascular conditions within the past 6 months: ... coronary artery bypass graft surgery",
"criterion": "coronary artery bypass graft surgery",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": "within the past 6 months"
}
]
},
{
"exact_snippets": "History of any one or more of the following cardiovascular conditions within the past 6 months: ... symptomatic peripheral vascular disease",
"criterion": "symptomatic peripheral vascular disease",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": "within the past 6 months"
}
]
},
{
"exact_snippets": "History of any one or more of the following cardiovascular conditions within the past 6 months: ... NYHA III or IV congestive heart failure",
"criterion": "NYHA III or IV congestive heart failure",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": "within the past 6 months"
}
]
}
]
},
{
"line": "* Poorly controlled hypertension.",
"criterions": [
{
"exact_snippets": "Poorly controlled hypertension",
"criterion": "hypertension",
"requirements": [
{
"requirement_type": "control",
"expected_value": "poorly controlled"
}
]
}
]
},
{
"line": "* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.",
"criterions": [
{
"exact_snippets": "History of cerebrovascular accident including transient ischemic attack (TIA)",
"criterion": "cerebrovascular accident",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "pulmonary embolism",
"criterion": "pulmonary embolism",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "untreated deep venous thrombosis (DVT)",
"criterion": "untreated deep venous thrombosis",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "treatment status",
"expected_value": "untreated"
},
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
}
]
},
{
"line": "* Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.",
"criterions": [
{
"exact_snippets": "Prior major surgery or trauma within 28 days prior to first dose of study drug",
"criterion": "major surgery or trauma",
"requirements": [
{
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
]
},
{
"exact_snippets": "presence of any non-healing wound, fracture, or ulcer",
"criterion": "non-healing wound, fracture, or ulcer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Evidence of active bleeding or bleeding diathesis.",
"criterions": [
{
"exact_snippets": "Evidence of active bleeding",
"criterion": "active bleeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "bleeding diathesis",
"criterion": "bleeding diathesis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.",
"criterions": [
{
"exact_snippets": "Known endobronchial lesions",
"criterion": "endobronchial lesions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "lesions infiltrating major pulmonary vessels",
"criterion": "lesions infiltrating major pulmonary vessels",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Hemoptysis in excess of 2.5 ml within 8 weeks of first dose of study drug.",
"criterions": [
{
"exact_snippets": "Hemoptysis in excess of 2.5 ml within 8 weeks of first dose of study drug.",
"criterion": "hemoptysis",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 2.5,
"unit": "ml"
}
},
{
"requirement_type": "time frame",
"expected_value": "within 8 weeks of first dose of study drug"
}
]
}
]
},
{
"line": "* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.",
"criterions": [
{
"exact_snippets": "serious and/or unstable pre-existing medical ... condition",
"criterion": "pre-existing medical condition",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "serious and/or unstable"
}
]
},
{
"exact_snippets": "serious and/or unstable pre-existing ... psychiatric ... condition",
"criterion": "pre-existing psychiatric condition",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "serious and/or unstable"
}
]
},
{
"exact_snippets": "serious and/or unstable pre-existing ... other condition",
"criterion": "pre-existing other condition",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "serious and/or unstable"
}
]
}
]
},
{
"line": "* Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.",
"criterions": [
{
"exact_snippets": "Unable or unwilling to discontinue use of prohibited medications",
"criterion": "discontinuation of prohibited medications",
"requirements": [
{
"requirement_type": "ability or willingness",
"expected_value": true
}
]
},
{
"exact_snippets": "for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug",
"criterion": "discontinuation duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 14,
"unit": "days"
}
]
}
}
]
},
{
"exact_snippets": "for the duration of the study",
"criterion": "discontinuation duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "for the duration of the study"
}
]
}
]
},
{
"line": "* Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib. A neoadjuvant or adjuvant chemotherapy must be finished at least 6 month before study entry.",
"criterions": [
{
"exact_snippets": "Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib",
"criterion": "anti-cancer therapies",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": [
"radiation therapy",
"surgery",
"tumor embolization"
]
},
{
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 14,
"unit": "days"
}
]
}
}
]
},
{
"exact_snippets": "Treatment with any of the following anti-cancer therapies: ... chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib",
"criterion": "anti-cancer therapies",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": [
"chemotherapy",
"immunotherapy",
"biologic therapy",
"investigational therapy",
"hormonal therapy"
]
},
{
"requirement_type": "time since treatment",
"expected_value": "14 days or five half-lives of a drug (whichever is longer)"
}
]
},
{
"exact_snippets": "A neoadjuvant or adjuvant chemotherapy must be finished at least 6 month before study entry",
"criterion": "neoadjuvant or adjuvant chemotherapy",
"requirements": [
{
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "months"
}
]
}
}
]
}
]
},
{
"line": "* Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.",
"criterions": [
{
"exact_snippets": "Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1",
"criterion": "ongoing toxicity from prior anti-cancer therapy",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "Grade"
}
}
]
},
{
"exact_snippets": "ongoing toxicity from prior anti-cancer therapy ... that is progressing in severity",
"criterion": "ongoing toxicity from prior anti-cancer therapy",
"requirements": [
{
"requirement_type": "progression",
"expected_value": true
}
]
},
{
"exact_snippets": "except alopecia",
"criterion": "alopecia",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
},
{
"line": "* Grade 3 or 4 diarrhea.",
"criterions": [
{
"exact_snippets": "Grade 3 or 4 diarrhea.",
"criterion": "diarrhea",
"requirements": [
{
"requirement_type": "severity",
"expected_value": [
"Grade 3",
"Grade 4"
]
}
]
}
]
},
{
"line": "* Peripheral polyneuropathy > NCI Grade.",
"criterions": [
{
"exact_snippets": "Peripheral polyneuropathy > NCI Grade",
"criterion": "peripheral polyneuropathy",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 0,
"unit": "NCI Grade"
}
}
]
}
]
},
{
"line": "* Pregnant or lactating women.",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Men or women who are planning a pregnancy within the next six months.",
"criterions": [
{
"exact_snippets": "Men or women who are planning a pregnancy within the next six months.",
"criterion": "planning a pregnancy",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within the next six months"
}
]
}
]
},
{
"line": "* Participation in another clinical trial with investigational agents within the last 30 days prior to study start.",
"criterions": [
{
"exact_snippets": "Participation in another clinical trial with investigational agents within the last 30 days prior to study start.",
"criterion": "participation in another clinical trial",
"requirements": [
{
"requirement_type": "time since last participation",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
]
}
]
},
{
"line": "* The patient is a colleague or employed by the study investigator or by an involved institution including the sponsor of the study.",
"criterions": [
{
"exact_snippets": "The patient is a colleague or employed by the study investigator",
"criterion": "employment status with study investigator",
"requirements": [
{
"requirement_type": "employment",
"expected_value": true
}
]
},
{
"exact_snippets": "employed by ... an involved institution including the sponsor of the study",
"criterion": "employment status with involved institution or sponsor",
"requirements": [
{
"requirement_type": "employment",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient is detained in a psychiatric unit or imprisoned.",
"criterions": [
{
"exact_snippets": "Patient is detained in a psychiatric unit",
"criterion": "detention in psychiatric unit",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Patient is ... imprisoned",
"criterion": "imprisonment",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}